Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Primary Purpose
Dental Plaque, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)
manual toothbrush (elmex® Inter X medium toothbrush)
manual toothbrush (elmex® Inter X medium toothbrush)
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring orthodontics, toothbrush, interdental brush, oral hygiene
Eligibility Criteria
Inclusion Criteria:
- no systemic diseases
- orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
- informed consent
Exclusion Criteria:
- presence of caries lesion
- antibiotic therapy within the previous 6 months
- diagnosis of early onset periodontitis
Sites / Locations
- Department of Orthodontics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Plaque Indices
Gingival Indices
Secondary Outcome Measures
Periodontal parameters
Microbiological parameters
Molecularbiological parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681135
Brief Title
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Official Title
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sebastian Zingler
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Gingivitis
Keywords
orthodontics, toothbrush, interdental brush, oral hygiene
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
Other Intervention Name(s)
Philips Sonicare® FlexCare
Intervention Description
toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Intervention Type
Device
Intervention Name(s)
manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)
Other Intervention Name(s)
elmex® Inter X medium toothbrush / interdental brush Curaprox®
Intervention Description
toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets
Intervention Type
Device
Intervention Name(s)
manual toothbrush (elmex® Inter X medium toothbrush)
Other Intervention Name(s)
elmex® Inter X medium toothbrush
Intervention Description
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Intervention Type
Device
Intervention Name(s)
manual toothbrush (elmex® Inter X medium toothbrush)
Other Intervention Name(s)
elmex® Inter X medium toothbrush
Intervention Description
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Primary Outcome Measure Information:
Title
Plaque Indices
Time Frame
every 4 weeks for 3 months
Title
Gingival Indices
Time Frame
every 4 weeks for 3 months
Secondary Outcome Measure Information:
Title
Periodontal parameters
Time Frame
every 4 weeks
Title
Microbiological parameters
Time Frame
every 4 weeks
Title
Molecularbiological parameters
Time Frame
every 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no systemic diseases
orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
informed consent
Exclusion Criteria:
presence of caries lesion
antibiotic therapy within the previous 6 months
diagnosis of early onset periodontitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J. Lux, Professor
Organizational Affiliation
Department of Orthodontics, University of Heidelberg
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthodontics
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
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